Lacidipine, NL/H/2974/01-02/DC, 03.03.20 Package leaflet: Information for the user Lacidipine Teva 2 mg film-coated tablets Lacidipine Teva 4 mg film-coated tablets lacidipine Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Lacidipine Teva is and what it is used for 2. What you need to know before you take Lacidipine Teva 3. How to take Lacidipine Teva 4. Possible side effects 5. How to store Lacidipine Teva 6. Contents of the pack and other information 1. What Lacidipine Teva is and what it is used for Lacidipine Teva contains a medicine called lacidipine. This belongs to a group of medicines called ‘calcium channel blockers’. Lacidipine Teva helps to relax your blood vessels so that they get wider. This helps the blood to flow more easily and lowers the blood pressure. Lacidipine Teva tablets taken regularly as prescribed by your doctor will help to lower your blood pressure (to treat hypertension). 2. What you need to know before you take Lacidipine Teva Do not take Lacidipine Teva - If you are allergic to lacidipine, other calcium channel blocker medicines or any of the other ingredients of this medicine(listed in section 6). - If you have the heart problem severe ‘aortic stenosis’. This is a narrowing of a valve in your heart, which restricts blood flow Do not take Lacidipine Teva if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Lacidipine Teva. Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Lacidipine Teva if: • You have an uneven heart beat or any other heart problems • You have or have ever had any liver problems • If you have had a heart attack within the last month or if you get chest pains (angina) Children and adolescents Lacidipine Teva is not recommended for children and adolescents below 18 years of age. Other medicines and Lacidipine Teva Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines. Lacidipine, NL/H/2974/01-02/DC, 03.03.20 This is because Lacidipine Teva can affect the way some other medicines work. Also some other medicines can affect the way Lacidipine Teva works. In particular, tell your doctor or pharmacist if you are taking any of the following medicines: • medicines for high blood pressure • medicines to treat fungal infections • medicines to control your heart beat (called ‘anti-arrhythmics’) • medicines for depression called ‘tricyclic antidepressants’ • antibiotics (eg rifampicin) • medicines used to treat epilepsy (fits) • cimetidine - used for stomach problems • ciclosporin (immunosuppressive agent used e.g. for transplant recipients) • corticoids or tetracosactide for the treatment of inflammatory bowel disease (IBD), Crohn’s disease, arthritis and osteoarthritis. If you are having any blood tests, tell the person giving the test that you are taking this medicine. This is because Lacidipine Teva can affect results relating to your liver. Lacidipine Teva with food and drink You can take this medicine on an empty stomach or with food. Do not take this medicine with grapefruit juice. Pregnancy,breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines You may feel dizzy while taking Lacidipine Teva. If this happens, do not drive or use any tools or machines. Lacidipine Teva contains lactose and sodium If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’. 3. How to take Lacidipine Teva Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. It is important to take the right number of tablets at the right time of day. • The recommended dose is 2 mg every day preferably in the morning with or without food • After 3-4 weeks this may be increased to 4 mg every morning. • If necessary the dose may be increased again to 6 mg every morning which is the maximum daily dose. • Swallow the tablets whole with a drink of water. • Do not take with grapefruit juice. Lacidipine Teva 4mg: The tablet can be divided into equal doses. If you take more Lacidipine Teva than you should Lacidipine, NL/H/2974/01-02/DC, 03.03.20 If you take more of this medicine than you should, talk to your doctor or go to a hospital straight away. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed. Medical treatment may be necessary. An overdose is likely to cause effects including uneven heart beat, rapid shallow breathing, low blood pressure, cold clammy skin or feeling dizzy, faint, weak or sick. If you forget to take Lacidipine Teva If you miss a tablet then you should take it as soon as you remember on the same day. However, if it is nearly time for your next tablet then you should skip the dose you missed and take your next tablet as normal. Do not take a double dose to make up for a forgotten tablet. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor straight away if you notice the following side effect: • chest pain (angina) including chest pain that gets worse The following side effects have been reported: Common (may affect up to 1 in 10 people): • headache • dizziness • flushing • fast heart beat (tachycardia) or abnormal heart beat (palpitations) • upset stomach or feeling sick (nausea) • skin rash • an increase in the amount of urine you pass (polyuria) • feeling weak (asthenia) • swelling (oedema), particularly of the ankles • changes in results of blood tests relating to your liver Uncommon (may affect up to 1 in 100 people): • chest pain (angina) including chest pain that is getting worse • low blood pressure (hypotension) • fainting • swelling of the gums (gingival hyperplasia) Rare (may affect up to 1 in 1,000 people): • angioedema (allergic reaction that causes swelling of the face) • urticaria (Nettle rash) • muscle cramps Vey rare (may affect up to 1 in 10,000 people): • tremor • depression Unknown (frequency cannot be estimated from the available data): • tremors or tics and changes in muscle tone and slowness of movement Reporting of side effects Lacidipine, NL/H/2974/01-02/DC, 03.03.20 If you get any side effects , talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Lacidipine Teva Keep this medicine out of the sight and reach of children. The blister should be stored in the outer carton to protect the tablets from light. Do not use this medicine after the expiry date which is stated on the carton and blister pack after “EXP”. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Lacidipine Teva contains The active substance is lacidipine. Lacidipine Teva 2 mg film-coated tablets: one tablet contains 2 mg lacidipine. Lacidipine Teva 4 mg film-coated tablets: one tablet contains 4 mg lacidipine. The other ingredients are Tablet core: povidone K-30, lactose, sodium starch glycolate Type A, magnesium stearate -. Film-coating: titanium dioxide (E171 hydroxypropylmethylcellulose (E464), gum arabicum (E414), lactose monohydrate, talcum (E553b). 2 mg tablets contain iron oxide yellow (E172) and iron oxide red (E172). What Lacidipine Teva looks like and contents of the pack Lacidipine Teva 2 mg film-coated tablets: beige, biconvex, round film-coated tablets, debossed “2LC” on one side, plain on the other. Lacidipine Teva 4 mg film-coated tablets: white, biconvex, oval film-coated tablets, debossed “4”, breakline and “LC” on one side, plain on the other. The tablets are packed in aluminium blister strips. Lacidipine Teva 2 mg film-coated tablets are available in blister packs of 14, 15, 28, 30, 56, 60, 84, 90 and 98 tablets. Lacidipine Teva 4 mg film-coated tablets are available in blister packs of 14, 15, 28, 30, 56, 60, 84, 90, 98 and 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer <[To be completed nationally] > This medicinal product is authorised in the Member States of the EEA under the following names: Denmark: Lacidipin Teva Spain: Lacidipino Teva 4 mg comprimidos EFG Lacidipine, NL/H/2974/01-02/DC, 03.03.20 Italy: Lacidipina Teva 2 mg, 4 mg compresse rivestite con film The Netherlands: Lacidipine 2 mg, 4 mgTeva, filmohulde tabletten Slovenia: Lacidipin Teva 4 mg filmsko obložene tablete, United Kingdom: Lacidipine 2 mg, 4 mg film-coated tablets This leaflet was last revised in .